N/A
N=321
Trial of Individual Psychosocial Interventions for Cancer Patients
Advanced Solid Tumor Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01323309 ↗Enrolled (actual)
321
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) — 37.07; 38.28; 36.80; 42.22 scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Individual Meaning-Centered Psychotherapy (IMCP) (Behavioral); standard Individual Supportive Psychotherapy (ISP) (Behavioral); enhanced usual care (EUC) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R) |
37.07; 38.28; 36.80; 42.22; 41.09; 37.40 | — |
| SECONDARY Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy |
28.48; 28.19; 29.53; 34.59; 32.86; 31.88 | — |
| SECONDARY The Relative Impact of Individual Meaning-Centered Psychotherapy on Different Aspects of Meaning (e.g., Purpose, Coherence, Existential Vacuum), as Well as on Different Aspects of Spiritual Well-being (Meaning Versus Faith), |
3.73; 3.96; 3.53; 3.76; 3.61; 3.58 | — |
| SECONDARY Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress). |
2.89; 2.95; 2.19; 1.97; 2.62; 2.05 | — |
Summary
The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care.
We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training.
Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.
Eligibility Criteria
Inclusion Criteria
- 21 years of age and older
- Able to communicate and understand English well enough to complete assessments and intervention**
- Patients solid tumors with advanced disease receiving ambulatory care at MSKCC*.
- Distress Thermometer rating of 4 or greater*
- Patients who do not meet these eligibility criteria may be offered participation as a training case (See inclusion criteria for Training Cases below).
Subject Inclusion Criteria- Training Cases
- 21 years of age and older
- Able to communicate and understand English well enough to complete the intervention**
- Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC with a Distress Thermometer rating of 3 or less. or Patients with solid tumors who do not meet eligibility criteria for advanced disease receiving ambulatory care at MSKCC.
or Patients solid tumors with advanced disease receiving ambulatory care at MSKCC who have participated in a prior meaning focused intervention study. or Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC who have enrolled in this study, been assigned to the EUC arm, and completed all study requirements including follow-up assessments.
**The study treatment manual materials and assessments were designed and validated in English and are not currently available in other languages. Translation of the intervention and questionnaires into other languages would require reestablishing the reliability and validity of them. Therefore, participants must be able to communicate in English.
Exclusion Criteria
- In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection.
- Baseline Karnofsky Performance Rating Scale (KPRS) score below 60 or physical limitations sufficient to preclude participation in a 7 session outpatient psychotherapy intervention.
- In the judgment of the consenting professional, severe psychiatric disturbance sufficient that would preclude participation in the intervention (patients whose psychiatric disorder is well controlled on medication will be eligible).
Data sourced from ClinicalTrials.gov (NCT01323309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.